Metastatic TNBC treatment receives FDA nod
medwireNews: Sacituzumab govitecan has been given accelerated approval from the US FDA for the treatment of metastatic triple-negative breast cancer (TNBC) in patients who have received at least two prior therapies.
Sacituzumab govitecan is a Trop-2-directed antibody conjugated to SN-38, an active metabolite of the topoisomerase I inhibitor irinotecan. The agent showed efficacy in the IMMU-132-01 trial of heavily treated TNBC patients; a third of participants achieved an objective response to treatment, and this lasted 6 months or longer in over half of the responders.
The recommended dose of sacituzumab govitecan is 10 mg/kg given as an intravenous infusion on days 1 and 8 of a continuous 21-day treatment cycle and adverse events associated with treatment include a warning for severe neutropenia and diarrhea.
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